- Responsible for the statistical aspects of the protocol, study report and publications, ensuring quality and integrity of statistical deliverables.
- Provides expertise on statistical methodology, sample size calculations, and study design.
- Prepares Statistical Analysis Plans (SAPs), including development of well-presented mock-up displays for tables, listings, graphs, and figures.
- Conducts and participates in verification and quality control of analysis, ensuring that output meets expectations and is consistent with analysis described in SAP.
- Reviews electronic case report forms (eCRFs), database design to ensure protocol criteria are met and all data is captured as required to perform the planned analysis.
- Follows applicable Standard Operating Procedures (SOPs), and relevant regulatory guidelines (. ICH).
- Completes assigned tasks within agreed timelines.
- Minimum of 3 years of experience as a Biostatistician or a related discipline.
- Experience in epidemiological and/or non-interventional studies within a CRO, biotech or pharmaceutical company preferred.
- Solid understanding of statistical methods commonly used in non-interventional studies.
- Profound knowledge of regulatory guidelines (., FDA, EMA) and industry standards
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Structured and careful way of working, high result orientation.
- Reliability and high sense of responsibility.
- Excellent written and verbal communication skills.
- Ability to read, write, speak, and understand English.
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JR_Field MPS
1周前
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ARM-Healthcare-BJ - Beijing, 中国 - Ipsos
描述
Job DescriptionBiostatistician for Non-interventional studies (NIS) /
Real-World Evidence (RWE)
Tasks & Responsibilities:
Required education and experience: